Pfizer Inc. — Inlyta EMA EPAR public assessment report (EMEA/H/C/002406, 2012)
Pfizer Inc. · 2012 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of Pfizer's Inlyta (axitinib) for advanced renal cell carcinoma (RCC) after prior sunitinib or cytokine treatment led to marketing authorization. The report details the regulatory process, product information, and scientific discussions on quality, non-clinical, and clinical aspects. Pharmacokinetic and pharmacodynamic profiles, including metabolism, elimination, and drug interactions, were evaluated. The pivotal Phase III study (A4061032) demonstrated Inlyta's superior progression-free survival (6.7 vs. 4.7 months) and objective response rate (19.4% vs. 9.4%) compared to sorafenib in mRCC patients. Safety analysis covered adverse events like hemorrhages, gastrointestinal perforations, and hepatic effects, with risk minimization activities outlined. The positive benefit-risk balance supported the recommendation for approval.
Key findings — cited to the page
| axitinib-treated patients with Grade 3 or greater diarrhoea in pivotal study | 10.6 % | · p.72 |
| patients with Grade >3 haemoptysis | 0.1 % | · p.72 |
| patients experiencing Grade 3/4 haemorrhages | 1.9 % | · p.72 |
| incidence of treatment-related grade >3 AEs in Caucasians | 45.7 % | · p.76 |
| hypertension (grade 3-5) in sorafenib arm | 11.0 % | · p.86 |
| lipase increased (grade 3-5) in sorafenib arm | 3.1 % | · p.86 |
| diarrhoea (grade 3-5) in sorafenib arm | 7.0 % | · p.86 |
| palmar-plantar erythrodysaestesia syndrome (grade 3-5) in sorafenib arm | 16.1 % | · p.86 |
| fatigue (grade 3-5) in sorafenib arm | 3.7 % | · p.86 |
| incidence of treatment-related grade >3 AEs in Asians | 59.7 % | · p.76 |
| rash (grade 3-5) in sorafenib arm | 3.7 % | · p.86 |
| sorafenib-treated patients with Grade 3 or greater diarrhoea in pivotal study | 7.3 % | · p.72 |
Source: Pfizer Inc. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →